MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO LEFT IBO BLADE (10.0 X 0.38MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number	5100037902
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not returned to manufacturer.
Event or Problem Description
It was reported that during a reconstruction of maxilla with leforte osteotomy, the blade broke at the cutting end.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
The quality investigation is complete.
Event or Problem Description
It was reported that during a reconstruction of maxilla with leforte osteotomy, the blade broke at the cutting end.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: LEFT IBO BLADE (10.0 X 0.38MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8137655
• Report Number: 0001811755-2018-02691
• Device Sequence Number: 16536450
• Product Code: GFA
• UDI-Device Identifier: 04546540466822
• UDI-Public: 04546540466822
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 06/01/2022
• Device Catalogue Number: 5100037902
• Device Lot Number: 17157017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1